Senior Scientist, Analytical Development
Core
Lead analytical activities for pre-pivotal Phase I and Phase II biologic molecules, focusing on potency, biological activity, and comparability studies.
Role type
Senior Scientist, Analytical Development (Biologics)
Builds
Bioassay potency methods, analytical methods, and control strategies for biologic therapies.
Domain
Biopharmaceuticals / Biologics
Required skills
Bioassay method development, ELISA, qPCR, cGMP compliance, comparability studies, data integrity, technical mentoring, scientific reporting, patent filing support, cross-functional collaboration
Preferred skills
Biologics analytical development in biotech/pharma, CMC support, IND authoring, immunoassays, cell-based assays, Biacore, process-related impurity methods, laboratory automation, data governance
Technologies
ELISA, qPCR, Biacore, Laboratory Automation Systems
Responsibilities
Design and execute bioassay potency methods; troubleshoot and optimize analytical methods; author method development reports and transfer documents; oversee data generation for internal and outsourced testing; mentor less experienced colleagues; present scientific findings to senior staff and cross-functional teams.
Seniority
Senior, hands-on IC with mentorship responsibilities